Pyrogen Testing Market

The global Pyrogen Testing Market is valued at USD 1700.41 Million in 2024 and is projected to reach a value of USD 7059 Million by 2035 at a CAGR (Compound Annual Growth Rate) of 13.85% between 2025 and 2035.

Premium Insights

The Pyrogen Testing market is poised for substantial growth driven by escalating demand for pyrogenic products and strategic partnerships. Fujifilm Wako Chemicals, a company offering cutting-edge endotoxin testing instruments, including the Toxinometer ET-6000, is a noteworthy example of this trend. This advanced instrument integrates three primary testing methods: Gel-clot, KTA (Kinetic Turbidimetric Assay), and KCA (Kinetic Chromogenic Assay). What sets the Toxinometer ET-6000 apart is its user-friendly interface, allowing for the commencement of a new assay while another is still in progress, facilitating efficient sample retesting. Furthermore, Fujifilm Wako Chemicals has taken steps to enhance user experience and expand its product portfolio by introducing the Toxinometer ET-7000 Series in 2019. This series boasts computer-operated capabilities and a more intuitive design, ensuring ease of operation. In addition to meeting changing consumer expectations, these product improvements are crucial to the market growth for Pyrogen Testing as a whole.

• In 2018, the European pharmaceutical industry allocated approximately EUR 36,500 million to R&D, as the European Federation of Pharmaceutical Industries and Associations (EFPIA) reported in 2019. Such growing research and development (R&D) investments are driving the market growth
• North America generated more than 42.50% of revenue share in 2022
• Asia Pacific is expected to grow at the quickest rate from 2023 to 2030
• In 2022, the Assays, Kits & Reagents sector had the most market growth and contributed more than 56.5% of the overall revenue share.
• The LAL Tests segment revealed the most significant market growth, contributing more than 42.2% of the total revenue share in 2022
• The Pharmaceutical & Biotechnology Companies segment accounts for the most significant revenue of 37.2% in 2022

Economic Insights

During periods of economic downturn, healthcare expenditure might decrease, which can impact the demand for Pyrogen Testing. Conversely, during economic growth periods, healthcare investments usually increase, which can stimulate the demand for Pyrogen Testing. Regarding the supply chain, the Pyrogen Testing market depends on various stakeholders and their activities. These include raw material suppliers, Pyrogen Testing kits, reagents manufacturers, distributors, and end-users such as pharmaceutical companies, medical device manufacturers, and contract testing laboratories. In addition, the supply chain can be affected by fluctuations in raw material prices, disruptions in transportation and logistics, and changes in regulations governing the manufacturing and distribution of Pyrogen Testing products. For instance, changes in import/export regulations, such as the imposition of trade tariffs or trade barriers, can impact the supply chain and global distribution of Pyrogen Testing products.

Top Market Trends

• Rising incidence of infectious diseases: The incidence of infectious diseases is increasing worldwide due to globalization, climate change, and antibiotic resistance. For instance, between 25 and 30 million Americans are affected by about 7,000 uncommon diseases, according to the National Institutes of Health (NIH). This is driving the demand for Pyrogen Testing to ensure the safety of medical products.
• Increasing frequency of pandemics: The recent COVID-19 pandemic has highlighted the importance of Pyrogen Testing. The virus is a pyrogen, which can cause severe illness if not removed from medical products.
• Growing demand for personalized medicine: In the field of customized medicine, medicines are made specifically for each patient. This requires Pyrogen Testing to ensure the patient is not exposed to harmful substances.
• Growing R&D in the pharmaceutical and biotechnology industries: The pharmaceutical and biotechnology industries invest heavily in research and development. According to sources, the global pharmaceutical sector will spend over 238 billion dollars on research and development in 2021. This is leading to the development of new Pyrogen Testing more accurate and efficient methods.
• Increased awareness of food safety: Food safety is becoming increasingly important, as is evident. According to the WHO, foodborne illnesses kill 420,000 people annually and impact 600 million people worldwide. This drives the demand for Pyrogen Testing to ensure that food products are harmful bacteria-free.

Market Segmentation

The global Pyrogen Testing market is segregated as shown below:

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Based on Product & Service

The Assays, Kits, & Reagents to hold the Largest Share

Assays, Kits, and Reagents segment held the market share in 2022. The rising incidence of infectious diseases, rising awareness among pharmaceutical and biotechnology firms, technological improvements, regulatory scrutiny, and investments in R&D activities can all be credited with this trend. This segment is expected to grow further with the continuous advances in testing methods and the increasing demand for reliable and efficient Pyrogen Testing. Furthermore, the increasing regulatory scrutiny on the safety and quality of pharmaceutical and biotechnology products has also contributed to the development of this segment. It is necessary to use assays, kits, and reagents that adhere to the regulations set forth by regulatory organizations like FDA and EMA.

Based on Test Type

LAL Tests dominated the market

LAL Tests have the most significant market growth in 2022, owing to their reliability, rapidity, cost-efficiency, regulatory acceptance, and the ethical considerations associated with animal testing. These factors have made LAL Tests the preferred method for Pyrogen Testing in many industries, and their market growth is expected to continue. In addition, LAL Tests can detect both endotoxins and non-endotoxin pyrogens, expanding their utility beyond bacterial endotoxin detection. This versatility allows for broader application in various industries, including pharmaceuticals, medical devices, and cosmetics.

Based on End-user

Pharmaceutical & Biotechnology Companies led the market

Pharmaceutical and biotechnology companies mentioned the most extensive market growth in 2022. The increased production and development of healthcare goods, stringent regulatory requirements, attention to patient safety and HAIs, and technological developments in testing techniques are all factors that have contributed to the rise of the Pyrogen Testing market in the pharmaceutical and biotechnology industries. The necessity for thorough Pyrogen Testing will only expand as the need for safe and efficient pharmaceutical products and medical equipment does, propelling market expansion shortly.

Based on Region

North America will lead the market

The Pyrogen Testing market in North America has experienced substantial growth in 2022. Pyrogens are chemicals that, when injected into the body, can raise the body temperature. They can come from various sources, including bacteria, viruses, and fungi, and their presence in pharmaceutical products or medical devices can pose serious health risks to patients. The rising demand for secure pharmaceuticals and medical equipment is one of the primary reasons driving the development of the Pyrogen Testing market in North America. Strict regulations are in place by regulatory agencies like the FDA to guarantee the efficacy and safety of these items. Pyrogen Testing is an essential part of the quality control process, as it helps to identify and eliminate any potential sources of contamination.

Competitive Landscape

The competitive landscape for the Pyrogen Testing Market is constantly evolving and highly competitive. The market includes several key players who offer a range of Pyrogen Testing products and services. These players compete based on pricing, product quality, technological advancements, and customer support. For example, Thermo Fisher Scientific is a global leader in the life sciences industry, with a significant presence in the Pyrogen Testing market. The company offers Pyrogen Testing products, including endotoxin detection kits, instruments, and software solutions. In July 2020, to commercialize various specialized reagents for the monocyte activation test (MAT)-based Pyrogen Testing of parenteral pharmaceuticals and medical devices, Lonza Sales AG and Sanquin Reagents BV formed a strategic agreement.

The players in the global Pyrogen Testing market include Associates of Cape Cod Inc. (U.S.) among others.

Recent Market Developments

• In August 2023, Lonza introduced the Nebula® Absorbance Reader, a brand-new absorbance microplate reader that expands the companys lineup of instruments specially designed for quick endotoxin and Pyrogen Testing.
• In April 2023, Complete Technical Solutions (CQV) Ltd. ("CTS") has undergone a merger and purchase announced by Ellab. Ellabs corporate objective of growing its field services to become a full-solution provider in essential areas within the biotech and pharmaceutical industries is being further executed with the purchase of CTS.
• In June 2022, The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System), developed by Lonza, employs human serum instead of fetal bovine serum. This brand-new in vitro Pyrogen Testing method shows improved sensitivity for non-endotoxin pyrogen identification and diminished interference from complicated medicinal items such as biologics-based medications.

Segmentation of the Global Pyrogen Testing Market